Status:
COMPLETED
Onset of Effect of Mometasone Nasal Spray in Induced Allergic Rhinitis (Study P03431)
Lead Sponsor:
Organon and Co
Conditions:
Allergic Rhinitis
Eligibility:
All Genders
12+ years
Phase:
PHASE4
Brief Summary
This was a single-dose study to determine the time it takes for mometasone furoate nasal spray to go in effect, after a single dose of 2 sprays per nostril. Patients who are eligible were exposed to r...
Eligibility Criteria
Inclusion
- at least 12 years old,
- had a history of SAR to ragweed pollen for at least one year
- had a positive skin test (prick) to short ragweed allergen.
- if female, had a negative urine pregnancy test (HCG) at the Screening Visit, and prior to treatment on the Treatment Visit
- were non pregnant women of childbearing potential and used a medically acceptable, adequate form of birth control.
Exclusion
- developed signs or symptoms of bronchospasm, i.e., wheezing, dyspnea, and/or cough, during the priming sessions;
- had any significant medical condition which, in the judgment of the investigator, might interfere with the study or require treatment;
- had an upper respiratory or sinus infection within two weeks prior to treatment;
- had received escalating doses of immunotherapy, oral immunotherapy or short course (rush) immunotherapy for treatment of rhinitis;
- were female subjects who were pregnant, breast feeding, or premenarchal;
- could not adhere to concomitant medication prohibitions;
- had a known potential for hypersensitivity, allergy, or idiosyncratic reaction to mometasone furoate nasal spray;
- had asthma that requires systemic or inhaled corticosteroid treatment;
- had large nasal polyps, marked septum deviations, or any other nasal structural abnormality that significantly interferes with nasal airflow;
- had rhinitis medicamentosa;
- had any relevant abnormal vital sign due to an unknown underlying disease and considered by the investigator and Sponsor Monitor to contraindicate study participation.
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 21 2004
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT00783237
Start Date
December 1 2003
End Date
February 21 2004
Last Update
August 15 2024
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